Status:
ACTIVE_NOT_RECRUITING
Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens
Lead Sponsor:
SIFI SpA
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Brief Summary
Cataract surgery presents an extremely high success rate in improving vision and quality of life and it is currently the most commonly performed ophthalmic surgery, especially considering its growing ...
Detailed Description
This is an observational, non-controlled, prospective clinical investigation to evaluate long-term safety and performance of Mini 4 Ready Intraocular Lenses in cataract patients. Specifically the aim...
Eligibility Criteria
Inclusion
- Subjects will be deemed eligible for the study if all of the following inclusion criteria are met:
- Older than eighteen years of age at the time of surgery and diagnosed with cataract;
- Unilateral or bilateral cataract removal by phacoemulsification;
- Correction of resulting aphakia with the Mini 4 Ready IOL. Indication for use of the Mini 4 Ready should be previous to and not conditioned by study participation.
- In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days;
- Willing and able to complete all required postoperative visits;
- Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.
Exclusion
- Subjects participating in a concurrent clinical trial or who have participated in an ophthalmological clinical trial within the last 30 days.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06093880
Start Date
January 8 2024
End Date
July 1 2027
Last Update
July 23 2025
Active Locations (1)
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1
Daniela Nicolosi
Catania, Italy, 95025